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External Events

11 September 2008

UKCPA Cardiac Group Study Day

Venue: Wallacespace, Convent Garden, London

Additional information:
Updates in Cardiology


15 September 2008

Discovery Knowledge & Informatics Event (3-day)

Venue: Crowne Plaza, Brussels, Belgium

Additional information:

IAPC's 3rd Annual - DKI - Discovery Knowledge & Informatics Event. A platform at which to discuss and draw new inspiration for the most time specific innovations in knowledge and data management within the pharmaceutical industry. Topics will include:-

  • Maximising the benefits of your knowledge base: accessing the benefits and capabilities semantic based technology can provide.
  • Optimising your data management strategies: draw key understanding from time specific case studies.
  • Cutting drug discovery timelines by maximising the value of key experimental data.
  • Capitalising on your investment by overcoming visualisation problems when partnering.


17 September 2008

Pharma Mini MBA ~ Autumn School (3-day)

Venue: The Rembrandt Hotel, London

Additional information:
This intensive three day course covers the key areas of an MBA and applies these MBA tools and concepts to the Bio/Pharmaceutical industry, providing you with a firm foundation of the essential MBA thinking and terminology. Three modules will be covered in just three days of workshops minimising disruption to your normal work. To enhance the value of the course and minimise your time away from the office there is also optional pre and post-work set by the tutors (at no extra cost).


18 September 2008

Abridged Licence Applications - Generics, Well Established Use & Mixed Product Licences (2-day)

Venue: The Rembrandt Hotel, London

Additional information:
This seminar is concerned with the current aspects of abridged applications and will include information on new issues arising in relation to these applications (user testing, risk management plans). Safety, quality and efficacy will be addressed in an integrated fashion and the importance of application registration planning will be stressed. A basic knowledge of the application procedure will be assumed


18 September 2008

Medical Device Clinical Investigations and Evaluations (2-day)

Venue: The Rembrandt Hotel, London

Additional information:
This course has been designed specifically for those involved in gathering clinical data to support regulatory approval and marketing of medical devices. With the recent amendments to the Medical Device Directives there are more stringent requirements to ensure the quality of the data submitted for CE marking of devices, and the data which needs to be generated once the device is on the market.


22 September 2008

Drug Device Combinations Products - Practical Guidance on Borderline Issues and Combination Products (2-day)

Venue: The Rembrandt Hotel, London

Additional information:
The demarcation between medicinal products and devices is becoming evermore important. In addition, with the convergence of emerging novel technologies the number of drug/device combination products and medicinal devices incorporating a medicinal substance are increasing. At the same time cell therapy and tissue engineered products are being combined with both pharmaceuticals and medical devices. This seminar will provide practical advice on the borderline issues concerning these combination products and provide key guidance on the regulatory strategy to follow.


24 September 2008

Biotechnology for Non Biotechnologists (3-day)

Venue: The Cavendish Hotel, London

Additional information:
The purpose of this training course is to provide Non-Biotechnologists with the basic theory to understand Principles, Techniques and the Potentials of Biotechnology. Biotechnology combines disciplines such as Molecular Biology, Biochemistry, Chemistry, Microbiology, Chemical Engineering and Computing. This rapidly advancing science offers new and exciting opportunities to mankind, especially in the fight against disease.


24 September 2008

Advanced Pharmacovigilance - A 3-day Advanced Level Course

Venue: The Rembrandt Hotel, London

Additional information:
This course has been designed for persons with at least 2 years worth of knowledge in Drug Safety. It will provide a very comprehensive and yet practical assessment of the main Regulations required to produce a compliant reporting Company. The group interactive sessions will highlight everyday situations that are going to be requiring thought and application of the legislation in order to generate the necessary compliance that will satisfy regulatory inspections. As well as expanding your global safety knowledge, this course will enable you to enhance your team’s capabilities and compliance in terms of both the regulations and your Company’s expectations. This will provide you with an excellent platform to build and maintain a quality Pharmacovigilance Department/Organisation ready for any Pharmacovigilance Inspection.


25 September 2008

UKCPA Critical Care Group Study Day

Venue: Wallacespace, Convent Garden, London

Additional information:
Advanced Practitioner Meeting


26 September 2008

Time and Priority Management

Venue: The Rembrandt Hotel, London

Additional information:
This highly interactive one day course will provide you with time management principles and best practice tools and techniques so you will be able to return to the workplace able to focus your energy, take control and work more efficiently and improve productivity. How Effective are you at Managing your time in the Pharmaceutical Industry? How Effective are you at Managing your time in the Pharmaceutical Industry? Key Time Management Principles to apply to working in the pressured environment of the Pharmaceutical industry, Establishing Goals and Achieving them, Dealing with Common Time Stealers.


29 September 2008

Medical Device Regulatory Affairs In The Middle East (2-day)

Venue: The Rembrandt Hotel, London

Additional information:

Stay ahead of your competitors by understanding the regulatory requirements and market opportunities in this region. This seminar will provide an understanding of the key areas of medical device regulatory affairs in the Middle East. It will include an overview of the medical device regulatory environment in the Gulf States and provide a more detailed perspective of medical device regulations in other countries within this region, such as Israel, Iran and Jordan. The meeting will provide an opportunity to gain an insight into the regulatory requirements and discover successful submission pathways to achieve access to the markets in this region. There will also be time for interactive discussion and sharing of experiences with the panel of speakers throughout the day. Should you require any further information please contact Andrea James on: andrea.james@management-forum.co.uk.


2 October 2008

UKCPA - Respiratory Group Study Day

Venue: Novotel Hotel, Whitehall Quay, Leeds

Additional information:
Pandora's Box of Respiratory Medicine


2 October 2008

US FDA QSIT and CAPA Requirements for Medical Devices (2-day)

Venue: Harrington Hall Hotel

Additional information:
BENEFITS IN ATTENDING: Ensure your company is compliant with FDA requirements:-

  • Clarify FDA’s current focus
  • Understand FDA Quality System Regulation (CGMPs)
  • Discover how to prepare your company for FDA Inspections
  • Know how to respond to 483’s and Warning Letters
  • Take away practical tools and tips to improve your companies CAPA process
  • Understand how to use a risk based approach to initiating and monitoring CAPAs


7 October 2008

UKCPA Pain Management Group Study Day

Venue: Britannia Hotel, St James Street, Nottingham

Additional information:
An Introduction to Pain Management


7 October 2008

Regulatory Requirements for Pharmaceutical Products in Japan (3-day)

Venue: The Cavendish Hotel, London

Additional information:
This seminar will provide up-to-date coverage of the requirements that underpin successful drug development for pharmaceutical products in Japan. In a carefully structured programme, the speakers will cover the official regulatory sources but will also share the interpretation and alternatives for drug development in Japan that only people with hands-on experience can provide. While focusing primarily on the clinical and regulatory aspects involved in the development of a new medicinal product, the seminar will include overviews of the chemistry, manufacturing and controls (CMC) considerations for Japan and overviews of the current environments and requirements for the development of Biological Products and Generic drugs. Participants will be invited to put learning into practice through participation in case studies. It is anticipated that the seminar will be useful both as an introductory course and as a refresher course to people who need to have an up-to-date and wide knowledge of the subject areas.


8 October 2008

Microbiology for the Non Microbiologist (2-day)

Venue: Harrington Hall Hotel, London

Additional information:
Microbiological issues play a key part in the production and control of manufactured items. The object of this seminar is to provide non-microbiologists with an overview of the basic theory and practical relevance of microbiology as it relates to the working environment.


13 October 2008

Clinical Trials for Support Staff

Venue: The Rembrandt Hotel, London

Additional information:
This course will give participants an excellent understanding of the most important clinical trial activities. It will also provide an overview of the key GCP, Clinical Trial Directive and FDA requirements for running clinical trials, as well as helping to optimise the effectiveness and proactiveness of support staff in supporting and contributing to the clinical trial project team.


14 October 2008

CTD:Clinical Overview and Clinical Summary

Venue: The Rembrandt Hotel, London

Additional information:
The Common Technical Document Guideline is now the obligatory format in the EU, US, Japan and many territories worldwide including Canada and Switzerland, for registration applications. This meeting will present the regulatory guidelines and requirements, discuss current approaches to the content and preparation of the Clinical Overview and Clinical Summaries (module 2) and provide an update on the latest information and potential future developments.


16 October 2008

Introduction to the Medical Device Directives - A repeat of this successful course (2-day)

Venue: The Rembrandt Hotel, London

Additional information:
This seminar provides a comprehensive introduction to the European medical device legislation. It will explain the directives and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do, plus the documentation necessary to apply for the CE Mark. This is an excellent introduction from leading experts in the field.


17 October 2008

Introductory Overview of the Pharmaceutical Industry - Early Booking Recommended

Venue: The Rembrandt Hotel, London

Additional information:
Key benefits of attending this meeting:- Increase your understanding of the Pharma Industry, Develop your knowledge of the stages of drug development from drug discovery through to marketing, Understand the roles and responsibilities of key departments and how they work together, Demystify the technical terminology and jargon, Get to grips with the phases of Clinical Trials and regulatory processes.


23 October 2008

Immunology of Vaccines and Vaccine Development (2-day)

Venue: Harrington Hall Hotel, London

Additional information:
This seminar will provide an in-depth analysis of the mechanisms of action of the immune responsiveness. In addition, a detailed consideration of the immunology of important individual vaccines will be given. A regulatory perspective of the development and registration of new vaccines will be considered with reference to the EU guidelines for registration of vaccines. There will be ample opportunity for discussion of all topics related to the immunology of vaccines and vaccine development.


10 November 2008

Project Management for Pharmaceutical Professionals (2-day)

Venue: The Rembrandt Hotel, London

Additional information:
Drug development is a complex process which needs effective project management. With ever increasing pressures to complete the development of drugs as quickly as possible, the effective use of project management can provide essential tools and techniques to achieve this. Indeed effective project management can be a key factor to successful completion of bringing a drug to market. This course has been designed to provide you with a thorough understanding of project management skills, both technical and interpersonal skills. You will be provided with an integrated project tool kit which can easily be used with your existing or future project management tools. This tool kit has been used to significantly improve the success of pharmaceutical project in many pharmaceutical organisations. The course will show you how to use these project management skills to gain the most benefit from them in your projects


20 November 2008

Introduction to the Medical Device Directives - A repeat of this successful course (2-day)

Venue: The Rembrandt Hotel, London

Additional information:
This seminar provides a comprehensive introduction to the European medical device legislation. It will explain the directives and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do, including the documentation necessary to apply for the CE Mark. This is an excellent introduction from leading experts in the field.


21 November 2008

UKCPA Autumn Residential Symposium

Venue: Hinckley Island Hotel, Leicestershire

Additional information:


24 November 2008

Multi-tasking and Managing Managers - In the Pharmaceutical Industry

Venue: The Rembrandt Hotel, London

Additional information:
An interactive course designed to provide you with skills to manage multiple task, projects and deadlines as well as managing work from more than one source. How to Manage Multiple Projects and Priorities, Managing Multi-Tasking, Working with Managers who are out of the Office, Working with more than One Manager, Key Planning Techniques, Efficiency and Time Management Solutions


27 November 2008

The EU Pharmaceutical Dossier - CTD Modules 2.3 and 3 (2-day)

Venue: Hotel Majestic, Barcelona, Spain

Additional information:
The conference will provide a wide-ranging, up-to-date coverage of the pharmaceutical issues that underpin a successful marketing authorisation application. In a carefully-structured programme, delegates will learn about the key components of the EU licensing systems for substances for pharmaceutical use and for finished medicinal products. Delegates will learn about sources of official information and expert guidelines and will find out how to prepare the ‘Quality’ parts of the CTD(in Modules 1.3, 2.3 and 3).


4 December 2008

Royal Society of Medicine Conference - Drug Discovery in the 21st Century

Venue: Royal Society of Medicine, 1 Wimpole Street, London, W1G 0AE

Additional information:

Over the past few decades, there have been dramatic advances in the application of the molecular sciences to biology and medicine. One consequence of this is that post-genomic methodologies, cell culture systems, tissue engineering, biophysical techniques and computer-based procedures are increasingly applied within the sphere of drug discovery and development.

Animal models have traditionally been used to select the most suitable drug candidates for human studies. However, the relevance of paradigms based on animal pharmacotoxicology and animal disease models is now constantly being questioned, not least because of the emergence of gene-, cell- and human-specific protein therapeutics and medical nanotechnologies. These developments have highlighted the sometimes subtle, but often crucial, differences between human and animal responses to pharmacological intervention, and make the requirement for drug testing based on human systems an increasing necessity.

The aim of this symposium is to encourage dialogue between stakeholders and decision makers, with a view to identifying the future roles of scientifically-advanced and more-appropriate alternatives to animal research and testing in drug discovery and development.

For more information and to register on line please visit http://www.rsm.ac.uk/academ/discovery08.php. For further assistance, please contact Chloe Waite on 020 7290 3844 or chloe.waite@rsm.ac.uk


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